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Attempting to stay up on every filing in every medication abortion case could be a full-time job these days.  We have one of those already, so we tend to stick to court rulings.  The filings in the Fifth Circuit on the AHM appeal are something of an exception.  In addition to party briefs, the list of amici that have weighed in is long and impressive.  A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others.  Of course, the current FDA, represented by the current DOJ, should also know about FDA law, FDA authority, and the history of its decisions regarding mifepristone.

As we have said, FDA is not infallible and we see where too much deference to FDA or any agency can produce some bad results and constitutional problems.  However, FDA is supposed to be and, in our experience, really is the expert in evaluating whether and under what conditions a drug should be approved.  More specifically, it employs a staff of subject matter experts and is not shy about enlisting outside experts, as with advisory committees, when it needs more expert firepower.  Its staff has a broad view tied to public health considerations, available drug and non-drug treatment options, data that may not be publically available, and decades of experience with the subject matter.  That all matters because judges lack that expertise, broad view, and experience.  Second-guessing decisions made by someone with expertise you lack is a dicey proposition.

The internet and a variety of societal trends have contributed to what some have called “The Death of Expertise.”  We wrote many posts about and saw many more examples of this phenomenon in connection with people following non-experts or “doing their own research” to pursue atypical “treatment” for COVID-19 and/or ascribe a wide range of “complications” to the COVID vaccines.  This also includes “ology” confusion.  For instance, an anesthesiologist or proctologist is not the right expert to consult for big questions about immunology, virology, epidemiology, gynecology, or cochlear implant audiology, for that matter.  Rejecting the value of relevant expertise also make it much easier for personal views to predetermine the outcome of any “research” or “analysis.”  There is a reason why studies should have formal protocols in place before they begin.  Scientific method, the involvement of subject matter experts (e.g., a biostatistician for the stats), and efforts to maintain data integrity are among the criteria for doing good scientific research and analyzing the findings of research that has been done.  People, even judges, do not like to hear it, but people can get confused and come to unsupportable conclusions when they stray beyond their own areas of competency (if any).  Guidance from true experts with an interest in the truth may help, but only if you are willing to credit their expertise.

Without rehashing the analytical gaps of the decision in AHM from the Northern District of Texas and the partial stay order from the Fifth Circuit (later trumped by the complete stay from the Supreme Court), we can say that those judges did not have scientific or regulatory subject matter expertise and did not credit expertise (or discredit faux expertise) as they should have.  The appellate brief from FDA bears that out well.  We will not rehash the entirety of the brief, which you can see here.  Each of the three arguments FDA makes for reversal relies in part on the incontrovertible facts that FDA had expertise to address the medical issues related to mifepristone and exercised its collective judgment in reaching decisions that related to its expertise.  This is quite clear from the first ten pages of the brief, where there are (conservatively) eight separate references to FDA exercising its scientific judgment or utilizing its expertise to review scientific information.  In other contexts, a similar recounting would support preemption, primary jurisdiction, or just plain deference.  Here, even without all the legal trappings and detailed arguments, there is a sense in which this set of facts should be enough to conclude the AHM decision cannot stand within the context of a number of constitutional provisions, a bunch of federal laws, and a boatload of caselaw.  As FDA wrote in its summary of arguments:

While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies and other scientific information, the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies, offering demonstrably erroneous characterizations of the record.

Brief at 16.  FDA also noted that the court had relied on its “own interpretation of extra-record publications.”  Brief at 12.  See what we meant about the death of expertise and the likelihood that non-experts (i.e., those with a “lay understanding”) will get it wrong when they pretend to know more than the actual experts do?

In terms of FDA’s arguments, we will focus on the core standing issue and why FDA’s actions were lawful (and not arbitrary and capricious).  The time-bar of the challenge to the 2000 approval of mifepristone is, as we said before, pretty obvious.  Enough has been written on the district court’s resurrection and misinterpretation of the Comstock Act.  In addition, the lack of a particularized injury to create standing largely determines why the district court’s granting of sweeping “preliminary relief” under the guise of 5 U.S.C. § 705 was an abuse of discretion.  The core standing issue, from our perspective, is whether individual physicians who did not prescribe mifepristone demonstrated particularized injury from a violation of a legally protected interest by the specific FDA actions about which they have complained in a timely fashion.  The brief does a good job of explaining why the “injuries” the physicians claim they will suffer are tied to the 2000 approval of mifepristone and not to any FDA action they have challenged in a timely fashion.  Brief at 27.  The FDA actions properly at issue do not affect the physicians’ legally protected interests.  As Justice Kavanaugh wrote back when he was on the D.C. Circuit, complaints like these physicians’ are required by the Constitution to be directed “to the Executive and Legislative Branches, not the judiciary.”  Brief at 19-20 (quoting Coalition for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275, 1283 (D.C. Cir. 2012)).  The standing arguments that the district court had accepted were on all fours with the standing arguments the Supreme Court rejected in Summers v. Earth Island Inst., 555 U.S. 488, 495 (2009), where it said expanding standing as proposed would “make a mockery” of Article III.  Brief at 21-24.

The Fifth Circuit’s motions panel obviously came down, in that particular context, on the side of the district court on the standing issues discussed above.  A few things are worth noting, though.  First, as we pointed out previously, the Fifth Circuit stay order’s evaluation of standing relied heavily on arguments based on alleged impacts from 2023 FDA actions.  Those should not be considered because, in addition to occurring after the suit was filed, these plaintiffs did not challenge them.  Brief at 11 n.1.  Second, while it cited Spokeo, Inc. v. Robins, 578 U.S. 330, 339 (2016), and Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013), on the requirement of a particularized injury—but did not apply them correctly, as far as we are concerned—it did not cite Summers and account for its rejection of statistical arguments that some member of a plaintiff organization is likely to suffer a concrete injury at some point in the future.  See FDA v. Alliance for Hippocratic Med., ___ F.4th ___, 2023 U.S. App. LEXIS 8898, *13-23 (5th Cir. Apr. 12, 2023).  Third, FDA directly addressed some of the motions panel’s misunderstanding of the science and statistics in the record, including that “mifepristone does not exacerbate ectopic pregnancy; it simply is not effective in treating that condition.”  Brief at 29.  Given how overly sympathetic the motions panel was to the plaintiffs’ theorized “stress” and the possibility that they would have to face “the irreconcilable choice between performing their jobs and abiding by their consciences,” it seems that reversing on standing—at least with the initial panel—will be difficult.

In its argument that the record did not support that any FDA actions were arbitrary and capricious—as the Administrative Procedures Act requires to strike down an agency decision—FDA did argue for deference.  The decisions it cited were interesting choices.  Rather than Chevron, Auer, or Kisor, FDA cited the Roberts concurrence in the stay order in FDA v. American Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 578-79 (2021), and the Fifth Circuit’s decision in Sierra Club v. EPA, 939 F.3d 649, 680 (5th Cir. 2019).  Brief at 38-39.  The former spoke of FDA’s “background, competence, and expertise to assess public health” in the context of mifepristone and the latter to the “evaluation of complex scientific data within its technical expertise.”  As expected from the early pages of the brief, FDA also spelled out its exercise of medical and scientific judgment at each step of its evaluation of mifepristone.  It also explained the relevant provisions of the FDCA and its regulations over the relevant time period, including how the district court essentially invented FDA requirements so that it could then claim FDA did not follow its own requirements—and thus acted arbitrarily and capriciously.  See, e.g., Brief at 42-44 & 60-61.  If you are following medication abortion litigation, then we recommend reading this section of the FDA brief to gain an understanding of how the judgment of experts was the driving force for a number of decisions that plaintiffs later challenged based on their own non-expert, personal preferences.

Speaking of preferences, any evaluation of what the Fifth Circuit will do has to look at the panel assigned to decide the merits of the appeal.  When that panel was announced on Monday, we noted that two of the three judges had sat together on a panel that issued a truly bad decision last year reversing a defense verdict from the Taxotere MDL.  Because the reasoning in that decision was so lacking and ignorant of rules that civil litigators ought to know, we said this:

We will deviate from our general rule of not talking about the panel, but this one was quite unusual in its composition.  Although there are 26 judges on this court, all three of the judges on the panel were appointed by a recent one-term president.  Only one had any prior judicial experience—a short stint on a state intermediate appellate court—and the other two were political appointees under a particular governor.  Rather than speculate about the panel’s mastery of the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and Louisiana product liability law, we will just speculate that just about any other panel of the Fifth Circuit would have a different perspective.

This does not leave us very hopeful about this panel and underscores how labeling a jurist “conservative” has little meaning when it comes to the issues at play in AHM.  The fact remains, however, that this panel is not likely to have the last say.  It may very well fall to a rehearing en banc and/or the Supreme Court—each stocked with mostly “conservative” jurists—to restore some sanity to the mad world where FDA approvals can be wiped out retroactively more than two decades later.  In this case, as FDA notes, the drug at issue is one declared an “Essential Medicine” by the World Health Organization and is used in more than half of all medical interventions within its approved indication.  Brief at 1.  But what do all those public health experts and prescribing physicians know compared to a lay person who did his own research?